NOTICE: Applications
submitted in response to this Funding Opportunity Announcement (FOA) for
Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424
Research and Related (R&R) forms and the SF424 (R&R) Application
Guide.

APPLICATIONS MAY NOT
BE SUBMITTED IN PAPER FORMAT.

This FOA must be read
in conjunction with the application guidelines included with this announcement
in Grants.gov/Apply
for Grants (hereafter called Grants.gov/Apply).

A registration process
is necessary before submission and candidates are highly encouraged to start
the process at least four (4) weeks prior to the grant submission date. See Section IV.

The overall goal of NIH-supported career development programs is
to help ensure that a diverse pool of highly trained scientists are available
in adequate numbers and in appropriate research areas to address the Nation's
biomedical, behavioral, and clinical research needs.

Purpose: The
primary purpose of the Pathway to Independence Award (K99/R00) program is
to increase and maintain a strong cohort of new and talented NIH-supported
independent investigators. The program is designed to facilitate a timely
transition from a mentored postdoctoral research position to a stable
independent research position with independent NIH or other independent
research support at an earlier stage than is currently the norm. Prospective candidates are encouraged to contact the
relevant Institute or Center (IC) staff for IC-specific programmatic and budgetary
information: Table of Institute and Center
Contacts.

Funds Available and Anticipated Number of Awards: The total
amount to be awarded by the participating ICs and the number of awards
will depend upon the quality and merit of applications received and the
availability of funds. It is anticipated that 150 to 200 competing K99/R00
awards will be issued for this program in each fiscal year.

Budget and Project Period:Because the nature and scope of the proposed K99/R00 award
program will vary from application to application and the amounts provided by
the participating ICs are not uniform, it is anticipated that the size and
duration of each award will also vary. Although the financial plans of
the ICs provide support for this program, awards pursuant to this funding
opportunity are contingent upon the availability of funds and the receipt of a
sufficient number of meritorious applications.

PHS
398 Career Development Award Supplemental Form Component Sections: Items 2-5
(Candidate Information) and 10-13 (Research Plan) are limited to a total
of 25 pages.

Eligible
Institutions/Organizations:Institutions/organizations listed in Section III are eligible to apply.

Eligible
Project Director/Principal Investigator (PD/PI): Also referred to as the Candidate,
individuals with the skills,
knowledge, and resources necessary to carry out the proposed research and
career development activities are invited to work with their mentor and
sponsoring institution to develop an application for support. Individuals from
underrepresented racial and ethnic groups, individuals with disabilities, and
individuals from disadvantaged backgrounds are always encouraged to apply for
NIH support. See Section III.

Number
of PDs/PIs: Only one PD/PI may be designated on the application.

Number
of Applications: Candidates may only have one individual Career
Development Award application pending peer review at any time.

The overall objective of the NIH Research Career
Development Award program is to prepare qualified individuals for careers that
have a significant impact on the health-related research needs of the Nation. The
objective of the NIH Pathway to Independence Award (K99/R00) initiative is to
assist postdoctoral investigators in transitioning to a stable independent
research position with NIH or other independent research funding. One of the most challenging transitions in any research
career is the transition from postdoctoral trainee to independent scientist.
Recent reports from the National Research Council of the National Academies of
Science (Bridges to
Independence: Fostering the Independence of New Investigators in Biomedical
Research, and Advancing
the Nation’s Health Needs: NIH Research Training Programs) have highlighted
the need for enhanced efforts to foster the transition of postdoctoral
scientists from mentored environments to independence.

NIH believes that the creativity and innovation of new independent
investigators in their early career stages play an integral role in addressing
our Nation’s biomedical, behavioral, and clinical research needs. However, the
average age of first-time (new) Principal Investigators obtaining R01 research
funding from the NIH has risen to 42 years for Ph.D. degree holders and 44
years for M.D. and M.D./Ph.D. degree holders. The intent of the K99/R00
program is to help alleviate this trend and to assist new investigators in
transitioning to stable independent research positions at an earlier age and
with an enhanced probability of success in obtaining independent NIH or other
independent research support.

In addition to this initiative, NIH Institutes and Centers (ICs) support
a variety of other mentored career development programs designed to foster the
transition of new investigators to research independence, which may be more
suitable for particular candidates. Information describing all NIH Career
Development Award programs can be found at the K Kiosk -
Information about NIH Career Development Awards.

Nature of the
career/research transition opportunity

The K99/R00 award will
provide up to 5 years of support consisting of two phases. The initial
mentored phase will provide support for up to 2 years for the most promising
and exceptionally talented new investigators who have no more than 5 years of
postdoctoral research training experience at the time of initial application or
subsequent resubmission(s) and do not already have a full-time tenure track
assistant professor position (or equivalent). This initial phase of mentored
support will allow the candidate time to obtain additional training, complete
research, publish results, and bridge to an independent research position.
The candidate must propose a research project that will be pursued during the
K99 phase and transition into an independent project during the R00 phase of
the award. The candidate and mentor(s) together will be responsible for all
aspects of the mentored (K99 phase) career development and research program.
An individual may submit an application from an extramural or intramural
sponsoring institution/organization that has a rich and extensive research
program in the area of interest as well as the faculty, facilities and
resources to support the proposed research endeavor. The individual must
select an appropriate mentor with a track record of funded research related to the
selected research topic and experience as a supervisor and mentor. The
sponsoring institution must ensure that the candidate has the protected time
needed to conduct the proposed research.

Following the mentored
phase, the individual may request up to 3 years of support to conduct research
as an independent scientist at an extramural sponsoring
institution/organization to which the individual has been recruited, been
offered and has accepted a tenure-track full-time assistant professor position
(or equivalent). This support is to allow the individual to continue to work
toward establishing his/her own independent research program and prepare an
application for regular research grant support (R01). Support for the
independent phase, however, is not automatic and is contingent upon being
accepted by an appropriate extramural institution and the successful NIH
programmatic review of the individual’s mentored phase of the award.

Note: NIH Institutes and Centers have unique scientific
purviews and different program goals and initiatives. Therefore, candidates are
strongly encouraged to consult the following table for IC-specific programmatic and budgetary
information: Table of
Institute and Center Contacts.

This Funding
Opportunity Announcement (FOA) will use the NIH Pathway to
Independence Award (K99/R00) mechanism.The Project Director/Principal Investigator (PD/PI) (also
referred to as the Candidate) and his/her mentor will be solely responsible for
planning, directing, and executing the proposed project.

The candidate should follow the instructions
for budget information described in Section IV (6.F)
as well as in PHS 398 Career Development
Award Supplemental form Section 7.4.6 of the R&R 424 instructions, and
budget justification information.

The K99/R00 program must be tailored to meet
the individual needs of the candidate. Candidates may request up to 5 years of
support consisting of two phases. The initial phase will provide 1-2 years of
mentored support for highly promising, postdoctoral research scientists. This
phase will be followed by up to 3 years of independent support contingent on
securing an independent tenure-track or equivalent research position. R00 award
recipients are expected to apply for additional NIH or other independent
research grant support during the independent phase of the award.

2. Funds Available

Because the nature and scope of the proposed K99/R00
award program will vary from application to application and the amounts
provided by the participating ICs are not uniform, it is anticipated that the
size and duration of each award will also vary. Although the financial plans of
the ICs provide support for this program, awards pursuant to this funding
opportunity are contingent upon the availability of funds and the receipt of a
sufficient number of meritorious applications.

2.A. Allowable Costs

The K99/R00 award has
two phases: a mentored K99 phase of up to 2 years at an eligible extramural
sponsoring institution/organization or NIH intramural laboratory followed by an
independent scientist phase of up to 3 years sponsored by an extramural
institution/organization to which the individual has been recruited.
Individuals who receive mentored phase support and are subsequently recruited
to positions at NIH intramural laboratories will not receive the independent
scientist phase of the award.

Mentored Phase of the
Pathway to Independence Award Program (K99)

The total cost per year
for the initial mentored phase generally should not exceed $90,000 at either an
NIH intramural or an extramural sponsoring institution site, but may be higher
in the case of individuals with exceptional salary needs. Salary and fringe
benefits may be requested up to the level provided by other Mentored Career
Awards offered by the awarding Institute or Center. Research support costs
will generally be provided up to $20,000 for a 12 month budget period. Some
ICs may offer higher research support costs. Candidates are strongly encouraged to consult the following
table for IC-specific programmatic
and budgetary information (see Table of Institute and Center
Contacts).

Candidates (intramural or
extramural) are required to commit a minimum of 75% of full-time professional
effort (i.e. minimum of 9 person-months) to the pursuit of their career
development and research experience during the mentored phase. This experience
may also include activities such as completing research publications and
searching for an independent research position. Candidates may engage in
teaching and/or clinical duties as part of the remaining 25% of the candidate’s
full-time professional effort not covered by this award, as long as such duties
do not interfere with or detract from the proposed career development program.

Intramural: Mentored candidates in the NIH
intramural program will be supported by intramural funds provided by the NIH
Institute/Center intramural laboratory in which they are conducting their
research. Budget details for the mentored phase will be negotiated with the
sponsoring intramural laboratory Institute/Center and salary will be consistent
with that offered new scientists in similar positions.

Extramural: Mentored candidates in an
extramural sponsoring institution/organization will be supported by NIH
extramural funds. Salary must be consistent with the established salary structure at the institution from its own funds
to other staff members of equivalent qualifications, rank, and responsibilities
in the department concerned. Fringe benefits
should be requested based on the sponsoring institution’s rate. Research
expenses may include (a) tuition and fees related to career development; (b) supplies,
equipment and technical personnel; c) travel to research meetings or training;
and (d) statistical services including personnel and computer time. Indirect
costs will be provided at 8% of modified direct costs to extramural sponsoring
institutions, only.

The extramural sponsoring
institution may supplement the NIH salary contribution up to a level that is
consistent with the institution's salary scale. However, supplementation may
not be from Federal funds unless specifically authorized by the Federal program
from which such funds are derived. In no case may additional PHS funds beyond
those provided in the K99 award be used for salary supplementation.
Institutional supplementation of salary must not require extra duties or
responsibilities that would interfere with the purpose of this award. Under
expanded authorities, however, institutions may rebudget funds within the total
costs awarded to cover salaries consistent with the institution's salary
scale. The total salary paid from NIH funds, however, may not exceed the
legislatively mandated salary cap. See https://grants.nih.gov/grants/policy/salcap_summary.htm.

Independent
Investigator Phase of the Pathway to Independence Award Program (R00)

The total cost for the
independent investigator R00 phase may not exceed $249,000 per year. This
amount includes salary, fringe benefits, research support allowance and
applicable indirect costs. Indirect costs will be reimbursed at the extramural
sponsoring institution’s indirect cost rate. Indirect costs requested by
consortium participants are included in the total cost limitation.

The salary requested
should be based on the person-months effort to be devoted to the R00 project, as
is the case for other research grant awards. The candidate is required to
devote a total of 75% of their full-time, 12 month professional effort to
research (i.e., a full-time 9 person-months). See eligibility below. However,
it may not be feasible to support this entire effort through the R00 project
alone. Recipients of the R00 phase awards may devote effort to other research
projects and may reduce effort on the R00 award if they receive additional independent
research support. Please note that a reduction of time devoted to a project by
25% or more from the level in an approved application will require NIH prior
approval as described in the NIH Grants Policy Statement.

Applicable to both
Mentored and Independent Phases

For information regarding
NIH policy on determining full-time professional effort for career awards see NOT-OD-04-056.
The requested salary must be consistent both with the established salary structure
at the institution and with salaries actually provided by the institution from
its own funds to other staff members with equivalent qualifications, rank, and
responsibilities in the department concerned. If full-time, 12-month salaries
are not currently paid to comparable staff members, the salary proposed must be
related appropriately to the existing salary structure. Confirmation of salary
is required prior to the issuance of an award. Fringe benefits based on the
sponsoring institution’s rate and the percent of effort are provided in
addition to the salary. See also “Eligible Individuals” below.

Indirect Costs: These costs also known as
Facilities and Administrative (F&A) costs, will be reimbursed at eight
percent (8%) of modified total direct costs for the extramural K99 phase, and at
the extramural sponsoring institution’s indirect cost rate for the R00 phase.

Any
individual(s) with the skills, knowledge, and resources necessary to carry out
the proposed research as the PD/PI is invited to work with his/her organization
to develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Project Director/Principal Investigator (PD/PI): Also referred to as the Candidate,
individuals with the skills,
knowledge, and resources necessary to carry out the proposed research and
career development activities are invited to work with their mentor and
sponsoring institution to develop an application for support. Individuals from
underrepresented racial and ethnic groups, individuals with disabilities, and
individuals from disadvantaged backgrounds are always encouraged to apply for
NIH support.

Citizenship
and Residency: U.S. citizens and non-U.S. citizens with the skills,
knowledge, and resources necessary to carry out the proposed research are
invited to develop an application for support. Information on citizenship/residency
status must be provided in the application as part of section 9.
Institutional Commitment to Candidate’s Research Career Development of the
PHS398 Career Development Award Supplemental Form. See also Section III.3.A
(Institutional Environment).

Degree and Research: Eligible PD/PIs include outstanding
postdoctoral candidates who have a clinical or research doctorate (including
Ph.D., M.D., D.O., D.C., N.D., D.D.S., D.M.D., D.V.M., Sc.D., D.N.S., Pharm.D.
or equivalent doctoral degrees) and who have no more than 5 years of
postdoctoral research training at the time of application (resubmissions must
also comply with this requirement). Clinicians (including those with M.D.,
D.D.S, D.V.M. and other licensed health professionals) in a clinical faculty
position that denotes independence in clinical responsibilities but not in
research may also be eligible for the K99/R00 award. See “Other-Special
Eligibility Criteria” below for more information.

Career
Level: This award is intended for and
limited to postdoctoral scientists who are in mentored training positions and
do not have sufficient research experience or institutional authority to lead an
independent research program. Individuals with a full-time tenure track
assistant professor position (or equivalent) at the time of application are not
eligible.

Level of Effort: Candidates must be able to commit a minimum of 9
person-months (75% of full-time professional effort) conducting research career
development activities associated with this award. The remaining 3 months
(25% effort) can be divided among other research, clinical, and teaching
activities only if these activities are consistent with the goals of the NIH K99/R00
Award, i.e., the candidate’s development into an independent investigator. For
information regarding NIH policy on determining full-time professional effort
for career awards, see NOT-OD-04-056.

At the time of award,
the candidate must have a “full-time” appointment at the academic institution
that is the applicant institution. Candidates who have VA appointments
may not consider part of the VA effort toward satisfying the “full time”
requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the
relevant Institute or Center prior to preparing an application to discuss their
eligibility.

Renewals: Awards are not renewable and
are not transferable from one PD/PI to another.

Individuals are NOT
eligible if they:

Have currently or previously held
an independent research faculty or tenure-track faculty position, or its
equivalent, in academia, industry or elsewhere; or

Have more than 5 years of related
postdoctoral research training at the time of initial application or
resubmission(s); or

Have been an independent principal
investigator on NIH research grants (e.g. R01, R03, R21), NIH career
development awards(e.g., K01, K07, K08, K23, K25), or other peer reviewed NIH
or non-NIH research grants over $100,000 direct costs per year, or project
leaders on sub-projects of program project (P01) or center (P50) grants.

Ph.D. (or equivalent research
doctorate degree) candidates in positions other than postdoctoral fellow
positions: It is
recognized that some institutions appoint postdoctoral fellows in positions
with other titles although they are still in non-independent training
positions. Candidates in such positions are encouraged to obtain
confirmation of their eligibility before they begin to prepare their
applications. It is incumbent upon the candidate to provide evidence that
the position he/she is in complies with the intent of this eligibility
requirement. Evidence for non-independence may include:

The candidate’s research is entirely funded by other
investigator’s
grants.

The candidate’s research is conducted entirely in
another investigator’s assigned space.

According to institutional policy, the candidate
cannot hire postdoctoral fellows or be the responsible supervisor of
graduate students.

According to institutional policy, the candidate is
not allowed to submit an application as the principal investigator of an
NIH research grant application (e.g., R01).

The candidate lacks other rights and privileges of
faculty, such as attendance at faculty meetings.

Conversely, evidence for independence, and therefore lack
of eligibility, includes:

The candidate has a full-time tenure track assistant
professor position (or equivalent).

The candidate received a startup package for support
of his/her independent research.

The candidate is eligible to apply for independent
research funding as the principal investigator of an NIH R01 or other equivalent
research grant.

Clinicians (including those with
M.D., D.D.S, D.V.M. and other licensed professionals) in positions not
designated as postdoctoral positions: Following clinical training or fellowship training
periods, clinicians often obtain a clinical faculty position that denotes
independence in clinical responsibilities but not in research. A clinical
faculty member who does not hold an independent research faculty position may
be eligible for the K99/R00 award, and should contact a Program Director at the
relevant NIH Institute for guidance. Clinicians in such positions are
encouraged to obtain confirmation of their eligibility before they begin to
prepare their applications. Such individuals may
also wish to consider other career awards available for junior faculty
development. See: K Kiosk -
Information about NIH Career Development Awards.

Candidates are strongly encouraged
to consult with the scientific/research contact person listed in Section VII of this announcement prior to the submission
of an application to discuss eligibility and IC-specific program and budget requirements
(See Table
of Institute and Center Contacts).

3.A. Special Requirements

Mentor(s): The candidate must name a primary mentor for the K99
phase, who together with the candidate is responsible for the planning,
direction, and execution of the program. The mentor should be recognized as an
accomplished investigator in the proposed research area and have a track record
of success in training research scientists. The mentor should have
sufficient independent research support to cover the costs of the proposed
research project in excess of the allowable costs of this award.
Candidates may also nominate co-mentors as appropriate to the goals of the
program. Primary mentors (and if at all possible, co-mentors) should be
full-time faculty at the sponsoring institution. If they are not (e.g.,
off-site mentors or co-mentors), strong justification for the appropriateness
of the mentoring relationship must be provided in the application. The primary
mentor and co-mentors should be committed to the development of the career of
the candidate as an independent investigator, as evidenced by the mentor and
co-mentor statements.

Institutional Environment: The
applicant institution must have a strong, well-established record of research
and career development activities and faculty qualified in biomedical,
behavioral, or clinical research to serve as mentors. The institution
must demonstrate a commitment to the development of the candidate as a
productive, independent investigator and be willing to allow the protected time
needed by the candidate. The candidate, mentor, and institution must describe
a research career development program that will maximize the use of this
environment, including available facilities and resources.

For
candidates for K99/R00 awards who are non-U.S. citizens with temporary U.S.
visas, the sponsoring institution must include information about their visa
status, and an assurance that their visas will allow them to remain in the
United States long enough to (a) transition to an independent research career
in the U.S. during the proposed mentored (K99) phase and (b) be productive on
the research project in the U.S. for the duration of the proposed independent
research (R00) phase. This information must be included as part of section 9.
Institutional Commitment to Candidate’s Research Career Development of the
PHS398 Career Development Award Supplemental Form.

Candidates may have only one
individual career development award application pending peer review at any time.

Section IV. Application and Submission Information

To
download a SF424 (R&R) Application Package and SF424 (R&R) Application
Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for
Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow
the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

The individual designated as PD/PI
on the application must be registered also in the NIH eRA Commons prior to the submission of the application.

The PD/PI must
hold a PD/PI account in the Commons. The applicant should not share a Commons account for both an Authorized Organization
Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a
PD/PI role and an Internet Assisted Review (IAR) role, both roles should exist
under one Commons account.

This registration/affiliation must
be done by the AOR/SO or his/her designee who is already registered in the Commons.

The PD/PI and AOR/SO
need separate accounts in the NIH eRA Commons since both are authorized to view
the application image.

Note: If
a PD/PI is also an NIH peer-reviewer the DUNS number obtained and used in the
reviewer role may NOT be used and is not applicable to any Grant Application to
the Federal Government. This DUNS number is different from the DUNS number used
by the applicant organization. The individual DUNS number should be used only
for the purposes of personal reimbursement.

Several of the steps of
the registration process could take four weeks or more. Therefore, the applicant
should immediately check with his/her business official to determine whether
their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept
electronic applications only from organizations that have completed all
necessary registrations.

1. Request Application Information

Applicants must
download the SF424 (R&R) application forms and the SF424 (R&R)
Application Guide for this FOA through Grants.gov/Apply.

Note:
Only the forms package directly attached to a specific FOA can be used. You
will not be able to use any other SF424 (R&R) forms (e.g., sample forms,
forms from another FOA), although some of the "Attachment" files may
be useable for more than one FOA.

Prepare all
applications using the SF424 (R&R) application forms and in accordance with
the SF424 (R&R) Application Guide for this FOA
through Grants.gov/Apply.

The SF424 (R&R)
Application Guide is critical to submitting a complete and accurate application
to NIH. Some fields within the SF424 (R&R) application components, although
not marked as mandatory, are required by NIH (e.g., the “Credential” log-in
field of the “Research & Related Senior/Key Person Profile” component must
contain the PD/PI’s assigned eRA Commons User ID). Agency-specific
instructions for such fields are clearly identified in the Application Guide.
For additional information, see “Frequently Asked Questions – Application
Guide, Electronic
Submission of Grant Applications.”

The SF424 (R&R)
application has several components. Some components are required, others are
optional. The forms package associated with this FOA in Grants.gov/APPLYincludes all applicable components, required and optional. A completed
application in response to this FOA includes the data in the following
components:

Applications may be submitted on or after the opening date and must be
successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization) on the application due date(s). (See above for all
dates.) If an application is not
submitted by the due date(s) and time, the application may be delayed in the
review process or not reviewed.

Once an application package has been
successfully submitted through Grants.gov, any errors have been addressed, and
the assembled application has been created in the eRA Commons, the PD/PI and the
Authorized Organization Representative/Signing Official (AOR/SO) have two
weekdays (Monday – Friday, excluding Federal holidays) to view the application
image to determine if any further action is necessary.

If everything is
acceptable, no further action is necessary. The application
will automatically move forward to the Division of Receipt and Referral in
the Center for Scientific Review for processing after two weekdays,
excluding Federal holidays.

Prior to the submission
deadline, the AOR/SO can “Reject” the assembled application and submit a
changed/corrected application within the two-day viewing window. This
option should be used if it is determined that some part of the
application was lost or did not transfer correctly during the submission
process, the AOR/SO will have the option to “Reject” the application and
submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to
ensure that the issues are addressed and corrected. Once rejected,
applicants should follow the instructions for correcting errors in Section
2.12, including the requirement for cover letters on late applications. The “Reject” feature should also be used if you determine that
warnings are applicable to your application and need to be addressed now.
Remember, warnings do not stop further application processing. If an
application submission results in warnings (but no errors), it will
automatically move forward after two weekdays if no action is taken. Some
warnings may need to be addressed later in the process.

If
the two-day window falls after the submission deadline, the AOR/SO will have
the option to “Reject” the application if, due to an eRA Commons or Grants.gov
system issue, the application does not correctly reflect the submitted
application package (e.g., some part of the application was lost or didn’t
transfer correctly during the submission process). The AOR/SO should first
contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course
of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.

If
the AOR/SO chooses to “Reject” the image after the submission deadline for a
reason other than an eRA Commons or Grants.gov system failure, a
changed/corrected application still can be submitted, but it will be subject to
the NIH
late policy guidelines and may not be accepted. The reason for this delay
should be explained in the cover letter attachment.

Both
the AOR/SO and PD/PI will receive e-mail notifications when the application is
rejected or the application automatically moves forward in the process after
two days.

Upon
receipt, applications will be evaluated for completeness by the Center for
Scientific Review, NIH. Incomplete applications will not be reviewed.

There will
be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives
the Grants.gov acknowledgments. The AOR/SO and the PD/PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific
Review Group is also in the Commons.

Note: Since email can be
unreliable, it is the responsibility of the applicant to check periodically on
their application status in the Commons.

The NIH will not
accept any application in response to this FOA that is essentially the same as
one currently pending initial merit review unless the applicant withdraws the
pending application. The NIH will not accept any application that is
essentially the same as one already reviewed. However, the NIH will accept
resubmission(s) application, but such application must include an Introduction
addressing the critique from the previous review.

All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants
Policy Statement.

NRSA Support: Ruth L. Kirschstein National Research Service Award
(NRSA) recipients who are selected for K99/R00 award funding must terminate
their NRSA support prior to receiving support from the K99/R00 award.

Salary Support: The salary requested
for the candidate must be consistent with both the established salary structure
for full-time staff appointments and with salaries actually provided by the
institution from its own funds to other staff members of equivalent
qualifications, rank, and responsibilities in the applicable department.

Research Development Support: The research
development support costs allowed for this program must be justified and be
consistent with the stage of development of the candidate and the proportion of
time to be spent in research or career development activities. Salary for
ancillary personnel support, such as mentors, secretarial and administrative
assistants is not allowed.

Pre-Award
Costs:Pre-award costs are
allowable. A grantee may, at its own risk and without NIH prior approval, incur
obligations and expenditures to cover costs up to 90 days before the beginning
date of the initial budget period if such costs: 1) are necessary to conduct
the project, and 2) would be allowable under the grant, if awarded, without NIH
prior approval. If specific expenditures would otherwise require prior
approval, the grantee must obtain NIH approval before incurring the cost. NIH
prior approval is required for any costs to be incurred more than 90 days
before the beginning date of the initial budget period.

The incurrence
of pre-award costs in anticipation of a competing or non-competing award
imposes no obligation on NIH either to make the award or to increase the amount
of the approved budget if an award is made for less than the amount anticipated
and is inadequate to cover the pre-award costs incurred. NIH expects the
grantee to be fully aware that pre-award costs result in borrowing against
future support and that such borrowing must not impair the grantee's ability to
accomplish the project objectives in the approved time frame or in any way
adversely affect the conduct of the project. See NIH Grants Policy Statement NIH Grants
Policy Statement.

Organizational DUNS: The applicant organization
must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with
Grants.gov. For additional
information, see “Frequently Asked Questions – Application Guide, Electronic
Submission of Grant Applications.”

Cover Letter: The PHS398 cover letter must
include the list of referees (including name, department affiliation, and
institution.

Other Project Information Component (Section 4.4): For
Project Summary/Abstract, briefly describe your current research AND the
research you propose to continue in the independent phase.

Senior/Key Person Profile (Section 4.5): Following the standard instructions for this section, delineate under separate
headings entitled Mentored K99 Phase and Independent R00 Phase, the key
personnel you plan to request for the mentored K99 phase and the projected
types of key personnel you plan to request in the independent R00 phase of the
Award. Please note that a mentor is required only for the initial K99
mentored phase.

The
following information must be included in the application in accordance with
the Supplementary Instructions for Research Career Awards in the SF424
(R&R) Application Guide (See Part I.7.5).

PHS 398 Career
Development Award Supplemental Form Component Sections: Items 2-5 (Candidate Information) and 10-13 (Research
Plan) are limited to a total of 25 pages. While each section of the Candidate
Information and Research Plan components needs to be uploaded separately as a
PDF attachment, applicants are encouraged to construct the Candidate Information
component and the Research Plan component as a single document, separating
sections into distinct PDF attachments just before uploading the files. This
approach will enable applicants to better monitor formatting requirements such
as page limits. All attachments must be provided to NIH in PDF format,
filenames must be included with no spaces or special characters, and a .pdf
extension must be used.

Appendix Materials: Candidates must follow the specific instructions on
Appendix materials as described in the SF424 (R&R) Application Guide (See https://grants.nih.gov/grants/funding/424/index.htm). Do not use the Appendix
to circumvent the page limitations of the Research Plan component. An
application that does not comply with the required page limitations may be
delayed in the review process.

6.A.
Candidate Information and Career Development Plan

Candidate’s Background:

Describe the
candidate’s commitment to a career in a biomedical or behavioral research field
relevant to the mission of one of the participating NIH ICs.

Describe the
candidate’s potential to develop into a successful independent investigator.

Describe the
candidate’s current as well as long-term research and career objectives.

If currently
supported by an institutional or individual Ruth L. Kirschstein NRSA, describe
the candidate’s current research training or fellowship program.

For
individuals in postdoctoral positions with other titles although still in
non-independent training positions, describe evidence of non-independence.

Career Goals and Objectives:

Present a
systematic plan that: (1) shows a logical progression from the candidate’s
prior research and training experiences to the training and research experiences
proposed for the mentored phase of the award (K99) and subsequently to
independent investigator status (R00); and (2) justifies the need for further mentored
career development to become an independent research investigator; and (3) that utilizes the relevant research and educational
resources of the institution..

Candidates
planning to be sponsored by an extramural institution should
consult with the proposed mentor to discuss the proposed research
training/career development plan for the mentored phase and the research plan
to be presented in the application for the subsequent independent scientist
phase.

If the candidate
is planning an NIH intramural laboratory for the mentored phase,
a mentor will need to be selected with whom the candidate can consult in
preparing and submitting the application for the intramural mentored phase of
the award. Individuals working at an NIH laboratory may work with their
current mentor, or with another intramural investigator, provided the research
experience proposed in this application will enhance the candidate’s scientific
career.

Career Development/Training Activities:

Describe the
career development plan and how it fits with the candidate’s goals and prior
experience. A systematic plan should be presented for obtaining the necessary
biomedical, behavioral, or clinical science background and research experience
to launch an independent research career. The career development plan must be
specifically tailored to meet the needs of the candidate and the ultimate goal
of achieving independence as a researcher.

Describe the
current training activities and how they relate to the career development plans
and the career goals of the candidate. Candidates must justify the need for the
award, both the mentored phase and the independent scientist phase, and must
provide a convincing case that the proposed period of support (1-2 years as a
mentored candidate followed by up to 3 years as an independent scientist) will
substantially enhance his/her career and/or will allow the pursuit of a novel
or promising approach to a particular research problem.

The candidate
should describe how the career development plan will promote the candidate’s
success and scientific independence. This plan should describe activities such
as those that will lead to new and/or enhanced research, grant-writing,
communication and laboratory management skills and knowledge. The candidate
should also describe how these skills will contribute to research productivity
and facilitate the development of new approaches and directions for
investigation. Courses or other activities that might allow the candidate to
expand the scope of his/her research in order to improve the potential for
success in gaining further independent funding is particularly encouraged.

The candidate
must describe the plan for evaluation of his/her progress during the mentored
phase and for the transition to the independent phase.

The candidate
and K99 phase mentor (see below) must describe plans for the transition to the
independent phase.

Training in the Responsible Conduct of Research:

Document
prior instruction in or propose plans to receive instruction in the responsible
conduct of research in terms of subject matter and duration of
instruction. An award cannot be made if an application lacks this
component.

Applications
not providing documentation of prior instruction in the responsible conduct of
research must include a description of a program to receive formal or informal
instruction in scientific integrity or the responsible conduct of research.

Applications
without plans for instruction in the responsible conduct of research will be
considered incomplete and may be returned to the candidate without review.

Although the
NIH does not establish specific curricula or formal requirements, all programs
are encouraged to consider instruction in the following areas: conflict of
interest, responsible authorship, policies for handling misconduct, policies
regarding the use of human and animal subjects, and data management.

The research plan should follow instructions outlined in
PHS 398 Career Development Award Supplemental form, including sections on
Specific Aims, Background and Significance, Preliminary Studies/Progress Report,
Research Design and Methods. The candidate should consult with the mentor(s)
regarding the development of this section.

The candidate
should describe his/her research that is relevant to the proposed R00 research
plan. Ideally, this would include a brief description of research performed
prior to the mentored phase, a description of the research planned during the
mentored phase and a detailed description of the research planned for the
independent phase. This narrative should describe what the candidate will
accomplish during the mentored phase research that will enable him/her to
launch an independent research program (i.e. what does the candidate still need
to accomplish during the mentored phase in order to compete successfully once independence
is achieved). It is anticipated that candidates will be best able to describe
their current and past research.

The research
description should demonstrate not only the quality of the candidate’s research
thus far but also the novelty, significance, creativity and approach of the R00
phase research, as well as the ability of the candidate to carry out the
research. Consequently, the research plan should provide a detailed rationale,
experimental approach and plan for the independent phase research.

The
application must also describe the relationship between the mentor’s research
and the candidate’s proposed research plan. The application should describe
how the candidate will gain independence from his/her mentors and achieve
separation of his/her scientific research program from that of the mentor(s).

If more than
one K99 phase mentor is proposed, the respective areas of expertise and
responsibility should be described.

Data and Safety Monitoring (when applicable):Individual NIH
institutes may have specific requirements for data and safety monitoring of
clinical trials. Candidates proposing to conduct clinical trials should
consult with relevant IC staff.Plans for data and safety monitoring
must be included in research plans involving Phase I or Phase II clinical
trials (see Federal Citations in Section VIII):
Generally, this requirement may be satisfied in the submitted application by
providing documentation that the sponsoring institution has an approved plan in
place and providing a brief description of the key elements of the plan.

6.C. Statement
of Support

Statement by Mentor, Co-Mentors, Consultants, Contributors
(All statements/letters should be appended to each other and uploaded as a
single pdf document):

The candidate
must name a primary mentor (sponsor), who, together with the candidate, is
responsible for the planning, direction, and execution of the K99 phase
program. The candidate may also identify co-mentors as appropriate to the
goals of the program.

The primary
mentor should be recognized as an accomplished investigator in the proposed
research area and have a track record of success in training individuals in
postdoctoral positions who have gone on to become independent investigators.

The mentor
should have sufficient independent research support to cover the costs of the
proposed research project in excess of the allowable costs of this award.

The
application must include a statement from the mentor(s) that provides: 1)
information on their research qualifications and previous experience as a
research supervisor; 2) a plan that describes the nature of the supervision and
mentoring that will occur during the proposed award period, including how the
candidate’s scientific and professional independence will be promoted; 3) a
description of the elements of the planned research training, including any
formal course-work; and 4) a plan for transitioning the candidate from the
mentored phase to the independent scientist phase of the award.

Similar information
must be provided by any co-mentor. If more than one mentor is proposed, the
respective areas of expertise and responsibility of each should be described.
Co-mentors should describe clearly how they will coordinate with the primary
mentor and the candidate.

Consultant(s)/Collaborator(s):
Signed statements must be provided by each consultant/collaborator confirming
their participation in the project and describing their specific roles.
Collaborators and consultants generally do not need to provide their
biographical sketches. However, information should be provided clearly
documenting the appropriate expertise in the proposed areas of
consulting/collaboration. Collaborators/consultants are generally not directly
involved in the development of the career of the candidate as an independent
investigator.

The mentor
must agree to provide annual evaluations of the candidate’s progress for the
initial mentored phase as required in the annual progress report, PHS 2590 (see Section VI.3
Reporting).

The mentor
must agree to review and comment on the extramural independent scientist (R00)
phase application (See Section VI.4 Activation of the
Independence Investigator Phase of Pathway to Independence Award (R00).

6.D.
Environment and Institutional Commitment to the Candidate

Description of Institutional Environment:

The
sponsoring institution must document a strong, well-established research and
career development program related to the candidate's area of interest,
including a high-quality research environment with key faculty members and
other investigators capable of productive collaboration with the candidate.

Describe the sponsoring
institution’s scientific environment including the resources and facilities
that will be available to the candidate.

Describe how
the institutional research environment is particularly suited for the
development of the candidate's research career and the pursuit of the proposed
research plan and progression to the R00 phase.

Institutional Commitment to Candidate’s Research
Career Development:

The
sponsoring institution must provide a statement of commitment to the
candidate's development into a productive, independent investigator and to
meeting the requirements of this award. It should be clear that the
institutional commitment to the candidate is not contingent upon receipt of the
K99/R00 award.

Provide
assurances that the candidate will be able to devote a minimum of 9 person-months (75% of full-time professional effort) to the development of their research program. The
remaining effort should be devoted to activities related to the development of
the candidate’s career as an independent scientist.

Provide assurance
that the research facilities, resources, and training opportunities, including
faculty capable of productive collaboration with the candidate, will be
available for the candidate’s planned career development and research programs.

Provide
appropriate time and support for any proposed mentor(s) and/or other staff
consistent with the career development plan.

If the
candidate is not a U.S. Citizen or permanent resident, the sponsoring
institution must include information about their visa status and an assurance
that the candidate’s visa provide sufficient time to complete both phases of
the K99/R00 award at a U.S. Institution.

6.E. Letters of Reference

Electronic submission of reference letters is a separate
process from submitting an application electronically. Reference letters are
submitted directly through the eRA Commons and do not use Grants.gov.
Therefore, candidates must follow the Supplemental Instructions in the SF424 R&R
Application Guide for Research Career Awards (Instructions, Part 7.3) (see https://grants.nih.gov/grants/funding/424/index.htm).

Letters of reference are an
important component of the application for the mentored career award. Candidates
for this career award must arrange to have at
least three (but no more than five) letters of reference submitted on their
behalf to the NIH eRA Commons Web site at https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new. The letters should be from well-established
scientists (referees) addressing the qualities of the candidate as well as
their potential for becoming an independent investigator. These letters should
be from individuals not directly involved in the application, but who are
familiar with the candidate’s qualifications, training, and interests,
including advisory committee members (if applicable).

The mentor/co-mentor(s) may also submit letters of
reference, but these letters will be considered independently of the three
required reference letters. Resubmission applications must include new letters
of reference.

Applications that are missing the required letters
of reference may be delayed in the review process or not accepted.

6.F. Budget for the Entire Proposed Period of Support

Allowable costs for this career award program are not
uniform throughout the participating Institutes and Centers; therefore the
salary amounts as well as the research development costs vary. See: Table of Institute and Center Contacts.

Cover Component (Section 4.2): For
Proposed Project (Start and Ending Date) indicate the total period of support
being requested including the mentored phase (up to 2 years) and the
independent phase (up to 3 years).

Budget
Component (Section 4.7): The first year's budget must be the mentored phase
budget, and is dependent upon the awarding IC salary policies for mentored K
programs.

Use the SF424 (R&R) Detailed Budget component and
review the instructions found in Part I.4.7(R&R Budget Component) of the
Application Guide. However for “K” applications only limited budget
information is required; therefore, candidates will also need to follow the
special instructions in Part I.7.4 of the SF 424 (R&R) [Supplemental
Instructions for Career Development Awards], noting the special instructions
that modify Section 4.7. In budget section A (Senior/Key Persons) include base
salary, person months and requested salary and fringe benefit information for
only the candidate. Base salary, and requested salary and fringe benefits
should reflect actual levels. Any adjustments based on IC policy limits will
be made at the time of the award. Sections B-E should be left blank. If a
dollar amount is required, enter 0 (zero) in the appropriate box. The total
Research Development Support amount requested for each year will be entered in
Section F, Materials and Supplies. In Section H enter Modified Total Direct
Costs under “Indirect Cost Type.” The Indirect Cost rate is 8% of modified
total direct cost. The Indirect Cost amount should be entered under “Funds
Requested.” Totals for Sections F, G, and H will be calculated automatically
for each year as well as for the Cumulative Budget. Within the direct cost
limitation for research development support, provide a detailed description
with justification for all equipment, supplies and personnel that will be used
to help achieve the career development and research objectives of this award.

Note: Intramural candidates should not
request a budget for the mentored phase of the award. If a dollar amount is
required, enter 0 (zero) in the appropriate box. The maximum total cost budget for the independent (R00) phase is $249,000
per year. No detailed budget information is required for the R00 phase at the
time of application for the K99 phase.

6.G. Resource Sharing Plan(s)

NIH
considers the sharing of unique research resources developed through
NIH-sponsored research an important means to enhance the value and further the
advancement of the research. When resources have been developed with NIH funds
and the associated research findings published or provided to NIH, it is important
that they be made readily available for research purposes to qualified
individuals within the scientific community. If the
final data/resources are not amenable to sharing, this must be explained in the
Resource Sharing section of the application (see https://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)

(a) Data Sharing Plan: Not
Applicable.

(b) Sharing Model Organisms:
Regardless of the amount requested, all applications in which the development
of model organisms is anticipated are expectedto include a
description of a specific plan for sharing and distributing unique model
organisms and related resources, or state appropriate reasons why such sharing
is restricted or not possible (see Sharing
Model Organisms Policy, and NIH Guide NOT-OD-04-042.)

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, candidates seeking funding for a
genome-wide association study are expected to provide a plan for
submission of GWAS data to the NIH-designatedGWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. A genome-wide association study is defined as
any study of genetic variation across the entire genome that is designed to
identify genetic associations with observable traits (e.g., blood pressure or
weight) or the presence or absence of a disease or condition. For further
information see Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies (NOT-OD-07-088) and https://grants.nih.gov/grants/gwas/.

Section V. Application Review Information

1.
Criteria

Only
the review criteria described below will be considered in the review process.

2.
Review and Selection Process

Applications
submitted for this funding opportunity will be assigned on the basis of
established PHS referral guidelines to the ICs for funding consideration.

Applications
that are complete will be evaluated for scientific and technical merit by (an)
appropriate scientific review group(s) in accordance
with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.

As
part of the scientific peer review, all applications will:

Undergo
a selection process in which only those applications deemed to have the
highest scientific and technical merit, generally the top half of
applications under review, will be discussed and assigned a priority
score;

Receive
a written critique; and

Receive
a second level of review by the appropriate national
advisory council or board.

Applications
submitted in response to this funding opportunity will compete for available
funds with all other recommended applications. The following will be
considered in making funding decisions:

Scientific
merit and quality of the proposed project as determined by peer review.

Relevance
of the proposed career development program, prior training, and commitment
of the candidate to becoming an independent research scientist.

Relevance
to the IC program priorities.

Availability
of funds.

Review
Criteria

The
overall goal of NIH-supported career development programs is to help ensure
that diverse pools of highly trained scientists are available in adequate
numbers and in appropriate research areas to address the Nation’s biomedical,
behavioral, and clinical research needs. The scientific review group will
address and consider each of these criteria in assigning the application's
overall score, weighting them as appropriate for each application.

Candidate

Career Development Plan

Research Plan

Mentor, Co-Mentor(s),
Consultant(s), and Collaborator(s)

Environment and Institutional Commitment
to the Candidate

The
application does not need to be strong in all categories to receive a high
priority score. These criteria are listed in logical order and not in order of
priority.

Candidate:

What is the candidate’s record of research productivity,
including the quality of peer-reviewed scientific publications?

What is the quality of the candidate's pre- and postdoctoral
research training experience, including expertise gained?

Based on the postdoctoral candidate’s experience, track
record and prior research training, what is the candidate’s potential to become
an outstanding, successful independent investigator who will contribute
significantly to his/her chosen field of biomedical-related research?

To what extent does the application provide evidence of the
candidate’s research creativity, and does this evidence suggest that the
candidate has the potential to develop a creative, independent research
program?

Evaluate the letters of reference. Are there letters from at least three
well-established scientists? Relative to the above review criteria, how do
these scientists evaluate the candidate? Do the letters provide strong
evidence that the candidate has a high potential to become an independent
investigator?

Given the
candidate’s prior training, proposed career development plan, and the referees’
evaluations, is it reasonable to expect that the candidate will be able to
achieve an independent, tenure-track or equivalent position within the time
period requested for the K99 phase of this award?

Career
Development Plan:

Are the content and duration of the proposed didactic and research
components of the career development plan appropriate for the candidate’s
current stage of scientific and professional development and proposed research
career goals?

Is the proposed career development plan likely to contribute
substantially to the scientific and professional development of the candidate
including his/her successful transition to independence?

For individuals currently supported by research training
programs, how does the proposed career development plan enhance or augment the
applicant’s training to date? Is the additional proposed training needed and
appropriate for the proposed research plan and the applicant’s future career
plans?

To what extent are the plans for evaluating the K99 awardee’s
progress adequate and appropriate for guiding the applicant towards a
successful transition to the independent phase of the award?

Is the timeline planned for the transition to the independent
phase of the award appropriate for the candidate’s current stage of scientific
and professional development and the career development proposed for the K99
phase of the award?

Research
Plan:

Is the proposed K99 phase research significant?

Are the scientific and technical merits of the K99 research
question, experimental design and methodology appropriate for the candidate’s
level of training, an appropriate vehicle for developing the research skills
described in the career development plan, and appropriate for developing a
highly successful R00 research program?

Is the proposed R00 phase research scientifically sound and a
logical extension of the K99 phase research? Is there evidence of long-term
viability of the proposed R00 phase research plan?

Evaluate
the innovation and creativity of the proposed R00 phase research, i.e.,
does the project address an innovative hypothesis or challenge existing
paradigms? Does the project develop or employ novel concepts, approaches,
methodologies, tools, or technologies?

To what extent is the proposed R00 phase research likely to
contribute significantly to our understanding of biomedical problems?

To what extent is proposed R00 phase research likely to
foster the career of the candidate as an independent investigator in biomedical
research?

Mentor(s), Consultant(s),
Collaborator(s):

To what extent does the mentor have a strong track record in
training future independent researchers?

To what extent are the mentor’s research qualifications and
experience, scientific stature, and mentoring track record appropriate for the
applicant’s career development needs?

Does the mentor(s) adequately address the above review criteria
including the candidate’s potential as well as his/her strengths and areas
needing improvement?

Evaluate the nature and extent of the proposed supervision
that will occur during the mentored phase of support, i.e. is it adequate, and
is the commitment of the mentor(s) to the applicant’s continued career
development appropriate?

Does the mentor have a comprehensive plan to support the
proposed K99 phase career development and research plans as well as the
candidate’s efforts to transition to independence? Is this plan adequate and
appropriate?

Are the consultants’/collaborators’ research and/or mentoring
qualifications appropriate for their roles in the proposed K99 phase of the
award?

Environment and Institutional Commitment
to the Candidate (K99 Phase):

To what extent does the institution provide a high quality
environment for the candidate’s development? To what extent are the research
facilities and educational opportunities, including collaborating faculty,
adequate and appropriate for the candidate’s research and career development
goals during the K99 phase of the award?

What evidence is provided that the K99 sponsoring institution
is strongly committed to fostering the candidate’s development and transition
to the independent (R00) phase?

Is there adequate assurance that the required (minimum of
75%) effort of the candidate will be devoted directly to the research training,
career development, and research activities described in the proposed career
development and research plans?

2.A. Additional Review
Criteria

In addition to
the above criteria, the following items will be considered in the determination
of scientific merit and the rating:

Training in the responsible conduct of
research: Does
the application include appropriate and adequate documentation of prior instruction in or plans for training in the
responsible conduct of research?

Resubmission(s):Are the responses to comments
from the previous scientific review group adequate? Are the improvements in the
resubmission application appropriate?

Protection of Human Subjects from Research Risk: The involvement of human
subjects and protections from research risk relating to their participation in
the proposed research will be assessed. See the “Human Subjects Sections” of
the PHS398 Research Plan component of the SF424 (R&R), part I, 5.5.

Inclusion of Women, Minorities and Children in Research: The adequacy of
plans to include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated. See the “Human Subjects Sections” of the PHS398
Research Plan component of the SF424 (R&R) part I, 5.5.

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to
be used in the project, the adequacy of the plans for their care and use will
be assessed. See the “Other Research Plan Sections” of the PHS398 Research Plan
component of the SF424 (R&R), part I, 5.5.

Biohazards: If materials or procedures are proposed that are
potentially hazardous to research personnel and/or the environment, determine
if the proposed protection is adequate.

2.B. Additional Review
Considerations

Budget and Period of Support: Is the proposed budget and period of support
appropriate in relation to the proposed research and the career development
needs of the candidate? The priority score should not be affected by the
evaluation of the budget.

2.C. Resource Sharing Plans

When relevant, reviewers will be instructed to comment
on the reasonableness of the following Resource Sharing Plans, or the rationale
for not sharing the following types of resources. However, reviewers will not
factor the proposed resource sharing plan(s) into the determination of
scientific merit or priority score, unless noted otherwise in the FOA. Program
staff within the IC will be responsible for monitoring the resource sharing.

After the peer review of the application
is completed, the PD/PI will be able to access his or her Summary Statement
(written critique) via the NIH eRA Commons.

If
the application is under consideration for funding, NIH will request
"just-in-time" information from the candidate. JIT includes, but is
not limited to, updated salary information and confirmation, current Other
Support as well as Human Subjects and Animal certifications. Activation of the
JIT link in the eRA Commons is not an indication of a request for Just in Time
information. The applicant organization will be contacted by NIH grants
administration staff if this information is required. For details, applicants
may refer to the NIH Grants Policy Statement Part II: Terms and
Conditions of NIH Grant Awards, Subpart A: General.

A formal NoA will be provided as part of the
extramural mentored phase of the K99 award conducted at a domestic, sponsoring
extramural institution/organization. The NoA signed by the grants management
officer is the authorizing document. Once all administrative and programmatic
issues have been resolved, the NoA will be generated via email notification
from the awarding component to the grantee business official (designated in
item 12 on the Application Face Page). If a grantee is not email enabled, a
hard copy of the NoA will be mailed to the business official.

There will not be a formal Notice of Award (NoA) associated with
the mentored phase of the K99 award conducted in the NIH intramural program.
The awarding Institute will transmit to the successful candidate an approval
letter which will include the terms and conditions of the NIH intramural K99
award, as well as expectations for the transition to the independent phase
(R00) of the award.

Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award
costs. See Section IV.5 “Funding
Restrictions.”

The
following related administrative policies apply to NIH Research Career Award
(“K”) programs:

A. Evaluation: In carrying out its stewardship of human
resource-related programs, the NIH may request information essential to an
assessment of the effectiveness of this program. Accordingly, recipients are
hereby notified that they may be contacted after the completion of this award
for periodic updates on various aspects of their employment history,
publications, support from research grants or contracts, honors and awards,
professional activities, and other information helpful in evaluating the impact
of the program.

B. Other Income: Awardees may retain royalties and fees for activities
such as scholarly writing, service on advisory groups, honoraria from other
institutions for lectures or seminars, fees resulting from clinical practice,
professional consultation or other comparable activities, provided these
activities remain incidental, are not required by the research and
research-related activities of this award, and provided that the retention of
such pay is consistent with the policies and practices of the grantee
institution.

All
other income and fees, not included in the preceding paragraph as retainable,
may not be retained by the career award recipient. Such fees must be assigned
to the grantee institution for disposition by any of the following methods:

The
funds may be expended by the grantee institution in accordance with the NIH
policy on supplementation of career award salaries and to provide fringe
benefits in proportion to such supplementation. Such salary supplementation
and fringe benefit payments must be within the established policies of the
grantee institution.

The
funds may be used for health-related research purposes.

The
funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks
should be made payable to the Department of Health and Human Services, NIH and
forwarded to the Director, Office of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for
the payment.

Usually,
funds budgeted in an NIH supported research grant for the salaries or fringe
benefits of individuals, but freed as a result of a career award, may not be
rebudgeted. The awarding component will give consideration to approval for the
use of released funds only under unusual circumstances. Any proposed retention
of funds released as a result of a career award must receive prior written
approval of the NIH awarding component.

C.
Leave Policies: Leave to another institution, including a foreign
laboratory, may be permitted if the proposed experience is directly related to
the purpose of the award. Only local institutional approval is required if
such leave does not exceed 3 months. For longer periods, prior written approval
of the NIH funding component is required. Details on the process for
submission of prior approval requests can be founds in the NIHGPS (rev. 12/03),
Requests for Prior Approval, at https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600130. Note: because of the relatively short duration of the K99 phase of the K99/R00
program, awardees are cautioned about the impact of any leave on their ability
to make sufficient progress to warrant transition to the R00.

A
copy of a letter or other evidence from the institution where the leave is to
be taken must be submitted to assure that satisfactory arrangements have been
made. Support from the career award will continue during such leave.

Leave
without award support may not exceed 12 months. Such leave requires the prior
written approval of the NIH component Institute or Center and will be granted
only in unusual situations.

Support
from other sources is permissible during the period of leave without award
support. Such leave does not reduce the total number of months of program
support for which an individual is eligible.

D.
Percent Effort Policies:Under certain circumstances, an
awardee may submit a written request to the awarding component requesting a
reduction in professional effort below 75 percent (equivalent to 9 person
months). Such requests will be considered on a case-by-case basis during the
award period. In no case will it be permissible to work at less than 50
percent effort (equivalent to 6 person months). The nature of the
circumstances requiring a change in the appointment status or percent effort
might include personal or family situations such as parental leave, child care,
elder care, medical conditions, or a disability. Permission to reduce the level of effort will not be
approved to accommodate job opportunities, clinical practice, or clinical
training. In each situation, the grantee institution must submit documentation
supporting the need for reduced effort along with assurance of a continuing
commitment to the scientific development of the awardee. In addition, the
awardee must submit assurance of his/her intention to return to at least 75
percent effort as soon as possible. During the period of reduced effort, the
salary and other costs supported by the award will be reduced accordingly.

E. Changes in Research or Career Development Program: Consultation with the
applicable NIH funding Institute or Center Program staff is strongly encouraged
when a change in the approved career development program and/or research plan
is being considered.

Individual
awards are made for career development in a specific research program. A
change in the specified scientific area of the research component of the career
development program requires prior approval of the awarding NIH Institute or
Center. A scientific rationale must be provided for any proposed changes in
the aims of the original peer-reviewed research plan. The new research plan
will be evaluated by staff of the awarding IC to ensure that the plan remains
within the scope of the original peer-reviewed research program. If the new
plan does not satisfy this requirement, staff could recommend that the award be
terminated.

F. Change of Institution or Termination: Consultation with the
applicable NIH funding Institute or Center program and/or grants management
staff is strongly encouraged when either termination or a change of institution
is being considered.

A
change of grantee institution normally will be permitted only when all of the
benefits attributable to the original grant can be transferred, including
equipment purchased in whole or in part with grant funds. In reviewing a
request to transfer a grant, NIH will consider whether there is a continued
need for the grant-supported project or activity and the impact of any proposed
changes in the scope of the project. A change may be made without peer review,
provided the PD/PI plans no significant change in research and career
development objectives and the facilities and resources at the new organization
will allow for successful performance of the project. If these conditions or
other programmatic or administrative requirements are not met, the NIH awarding
office may require peer review or may disapprove the request and, if
appropriate, terminate the award.

If
the K awardee is moving to another eligible institution, career award support
may be continued provided:

A
relinquishing statement is submitted by the original institution and a transfer
application is submitted by the new institution at least three months prior to
the transfer in order to allow the necessary time for administrative review by
the NIH awarding Institute or Center.

The
awardee must establish in the transfer application that the specific aims of
the research program to be conducted at the new institution are within the
scope of the original peer-reviewed research program, and that a new mentor has
been identified who has the appropriate research expertise and support to
provide adequate guidance to the awardee and research support for the awardee's
research program.

All
conditions of the award are met at the new institution.

The
period of support requested is no more than the time remaining within the
existing award.

When
a grantee institution plans to terminate an award, the Grants Management
Specialist listed on the Notice of Award (NoA) must be notified in writing at
the earliest possible time so that appropriate instructions can be given for termination.
The Director of the NIH awarding component may terminate an award upon
determination that the purpose or terms of the award are not being fulfilled.
In the event an award is terminated, NIH shall notify the grantee institution
in writing of this determination, the reasons, the effective date, and the
right to appeal the decision.

The Progress Report must include Sections (A) through
(F) as described in Section 2.2.6 (Progress Report Summary) in the general PHS
form 2590 instructions, as well as sections “G” through “J” as described in
Section 5 of the 2590 instructions. Evaluation of the awardee’s progress will
encompass the following:

A
demonstration of scientific progress toward achieving the aims of the research
as described in a brief summary of the studies and results obtained during the
prior funding period;

A
description of career development and research-related activities undertaken
during the prior funding period.

A
list of accomplishments such as publications, scientific presentation, new
collaborations, inventions, or project-generated resources made during the
prior funding period;

A
brief explanation of plans to address the specific aims during the next year of
support;

A
description of proposed career development and research-related activities for
the next year of support with a clear indication of percent effort devoted to
research/research training and other activities.

An
annual evaluation statement of the candidate’s progress by the mentor, as
required in the PHS 2590 continuation application instructions (item J. Mentor’s Report).

For
awardees sponsored by an extramural institution for the mentored support
phase, the mentor and Department or Division Chair must review the awardee’s
research training/career development progress and submit a report to the NIH
awarding component at least six months prior to the scheduled end of the
mentored phase of the award.

For
those awardees conducting their mentored phase research at an NIH intramural
laboratory, the intramural training director must include a statement
documenting the awardee’s progress.

Progress
of the awardee in securing a tenure-track full-time assistant professor
position (or equivalent).

A
final progress report, invention statement, and Financial Status Report are
required when an award is relinquished, when a recipient changes institutions,
or when an award is terminated.

Transition from the mentored phase to the independent phase is intended
to be continuous in time and,
except in unusual circumstances, the awarding NIH Institute/Center will not
extend the K99 phase beyond the 2-year limit.
To activate the independent phase of the grant, individuals must have been
offered and accepted a tenure-track, full-time assistant professor position (or
equivalent) at an eligible institution with appropriate infrastructure to
support the proposed research program and a history of external research
funding. Applicants are free to apply for independent phase positions
within the NIH intramural research program (IRP). However, should the
individual accept such a position in the IRP, the independent phase of the
award will not be activated. This is because NIH intramural scientists
are supported directly by NIH intramural funds and are not eligible for NIH
extramural grant awards. Such outcomes are consistent with the goals of
the K99/R00 award initiative.

The
application for the R00 phase of the award must be submitted no later than 2
months prior to the proposed activation date of the R00 award by the R00 phase
grantee organization. However, to avoid potential problems in activation,
applicants are strongly encouraged to contact their NIH program official as
soon as plans to assume an independent position develop, and not later than 6
months prior to the termination of the K99 phase of the award, to discuss plans
for transition to, and the application for, the R00 phase.

The
independent phase institution will submit an application on behalf of the
candidate for the R00 award using the PHS 398. The R00 application must
include:

A new face
page signed by the R00 phase institutional representative;

A new project
description page (the project summary or abstract should be updated to reflect
current plans for the R00 phase);

Detailed
budget pages for a non-modular budget;

Biographical
sketches;

A new
Resources page;

A brief description of progress made during the K99 phase that will serve
as the Final Progress Report for the K99 phase;

An updated
research plan (the specific aims should be updated to reflect current plans for
the R00 phase and the updated research plan should be briefly described in less
than 5 pages); and

A new
checklist.

In
addition, a letter from the R00 Department or Division Chairman describing the R00 institution’s commitment to the
candidate and plans for his/her career development should be submitted (see
below), as well as a final evaluation statement by the K99 phase mentor, if not
already provided.

These
materials should be sent directly to the awarding Institute or Center
(IC). Details are available at the NIH New Investigator Program website. The original
application plus one copy (preferably in a PDF format) are to be mailed to the
Financial or Grants Management contact person of the awarding NIH Institute or
Center listed in the Notice of Grant Award. The R00 application will be evaluated by extramural
program staff of the awarding component for completeness and responsiveness to
the program.

An
institutional commitment agreement will be required at the time of activation
of the independent phase of the award. This agreement should satisfy the
criteria described in the Career Development Award Section III of the PHS 398 application kit. In addition to
space, facilities, resources, and other support needed to conduct the proposed
research, the sponsoring institution must provide protected research time
(minimum of 75% effort) at least for the duration of the R00 award. The
start-up package and other institutional support must be described and should
be comparable to that given to other faculty recently hired into tenure-track or equivalent
positions. Institutions must provide a startup and salary package
equivalent to that provided to a newly hired faculty member who does not have a
grant; R00 funds may not be used to offset the typical startup package or to
offset the usual institutional commitment to provide salary for tenure-track
(or equivalent) assistant professors who are hired without grant support.
The R00 sponsoring institution should describe the candidate’s academic
appointment, bearing in mind that it must be tenure-track assistant professor
(or equivalent), and confirm that the appointment is not contingent on the
transfer of the award to the institution. The R00 phase institution must foster
and support the awardee’s ability to apply for and secure independent research
grant (R01) support.

The R00 award requires that a minimum of 75% effort be devoted to
research activities. Consequently, teaching, clinical duties and other
non-research activities should be minimal during the R00 award period.
NIHstaff may review start-up packages and other commitments between the
institution and candidate prior to activating the independent phase of the
award. It is suggested that the applicant and/or the hiring institution discuss
the institutional commitment with the relevant NIH institute program official
prior to submission of the R00 application. NIH will not activate the
independent phase if the institutional commitment is deemed inadequate.
Applicants who are approved to transition will receive a Notice of Grant Award
reflecting the new R00 grant mechanism, the dollar amount, and the new
recipient organization (if applicable).

The K99/R00 award is intended to facilitate successful transition to
independence. Consequently, a requirement for activation of the R00 phase is
successful completion of this transition. Applicants are encouraged (but not
required) to apply for independent positions at departments and institutions
different from where they conducted their mentored research. It is
important for all applicants, but especially so for applicants who intend to
stay at the mentored phase institution for the independent phase, to provide a
plan by which they will separate from their mentor and advance to
independence. Awardees are also encouraged to include a plan and timeline
for submitting an independent research grant application in a research area relevant
to the mission of an NIH awarding component.

Candidates
who are not approved to transition will receive written notification from the
awarding component communicating the rationale for the disapproval. This
letter typically will be sent within 60 days of receipt of the R00 application.

Although
the financial plans of the NIH Institute or Center provide support for this
program, awards pursuant to this funding opportunity are contingent upon the
availability of funds.

Termination
of the K99 award phase

If
transition from the K99 phase at an extramural institution to the R00 phase
occurs at the originally scheduled end date of the K99 award, then no specific
steps to terminate the K99 award are necessary. If the transition occurs
prior to the scheduled end date, then a revised Notice of Award will be issued
to terminate the K99 phase award. Carry-over of unspent funds from
a partially completed year in the K99 phase into the R00 phase may be
permitted.

Information
about the Pathway to Independence award program can be found in the NIH New Investigator
website. We encourage your inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential candidates.
Inquiries may fall into three areas: scientific/research (program), peer
review, and financial or grants management issues:

1.
Scientific/Research Contact(s):

Candidates should refer
to the NIH Web site (Table
of Institute and Center Contacts) for information regarding
each IC-specific programmatic and
budgetary information, and scientific/research
contact for this program.

Human Subjects
Protection:Federal regulations (45 CFR 46) require that applications
and proposals involving human subjects must be evaluated with reference to the
risks to the subjects, the adequacy of protection against these risks, the
potential benefits of the research to the subjects and others, and the
importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety
Monitoring Plan:Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The
establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risks
to the participants (“NIH Policy for Data and Safety Monitoring,” NIH Guide
for Grants and Contracts, https://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing
Research Data:Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (https://grants.nih.gov/grants/policy/data_sharing).Investigators should
seek guidance from their institutions, on issues related to institutional policies
and local institutional review board (IRB) rules, as well as local, State and
Federal laws and regulations, including the Privacy Rule. Reviewers will
consider the data sharing plan but will not factor the plan into the
determination of the scientific merit or the priority score.

Policy for Genome-Wide
Association Studies (GWAS): NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see https://grants.nih.gov/grants/gwas/.

Sharing of Model Organisms:NIH is committed to support
efforts that encourage sharing of important research resources including the
sharing of model organisms for biomedical research (see https://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh-Dole Act (see the NIH
Grants Policy Statement. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal are expected to include in
the application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.

Access to Research Data through the Freedom of
Information Act:The Office of Management and Budget (OMB) Circular A-110 has
been revised to provide access to research data through the Freedom of
Information Act (FOIA) under some circumstances. Data that are: (1) first
produced in a project that is supported in whole or in part with Federal funds;
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.

Inclusion of Women And Minorities in Clinical
Research:It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research” (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R) application; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical
Research:The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all clinical research, conducted or
supported by the NIH, unless there are scientific and ethical reasons not to
include them.

Required Education on the Protection of Human Subject
Participants:NIH policy requires education on the protection of human
subject participants for all investigators submitting NIH applications for
research involving human subjects and individuals designated as key personnel.
The policy is available at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):Criteria for Federal funding
of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this information
will be returned without review.

NIH Public Access Policy Requirement: In accordance with the NIH Public Access Policy,investigators
funded by the NIH must submit or have submitted for them to the
National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an
electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no
later than 12 months after the official date of publication. The
NIH Public Access Policy is available at (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html).For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable
Health Information:The Department of Health and
Human Services (HHS) issued final modification to the "Standards for
Privacy of Individually Identifiable Health Information", the
"Privacy Rule", on August 14, 2002. The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 that governs the protection of individually identifiable health
information, and is administered and enforced by the HHS Office for Civil
Rights (OCR).

Decisions about
applicability and implementation of the Privacy Rule reside with the researcher
and his/her institution. The OCR website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices: All applications and proposals for NIH
funding must be self-contained within specified page limitations. For
publications listed in the appendix and/or Progress report, Internet addresses
(URLs) or PubMed Central (PMC) submission identification numbers must be used
for publicly accessible on-line journal articles. Publicly accessible
on-line journal articles or PMC articles/manuscripts accepted for publication that
are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference
in either the Bibliography & References Cited section, the Progress Report
Publication List section, or the Biographical Sketch section of the NIH grant
application. A URL or PMC submission identification number citation may be
repeated in each of these sections as appropriate. There is no limit to the
number of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010:The Public Health Service
(PHS) is committed to achieving the health promotion and disease prevention
objectives of "Healthy People 2010," a PHS-led national activity for
setting priority areas. This FOA is related to one or more of the priority
areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.

Authority and
Regulations:This program is described in the Catalog of Federal Domestic Assistance athttp://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372. Awards are made
under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement.

The PHS strongly
encourages all grant recipients to provide a smoke-free workplace and
discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in
some cases, any portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development services are
provided to children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.

Loan
Repayment Programs:NIH encourages applications
for educational loan repayment from qualified health professionals who have
made a commitment to pursue a research career involving clinical, pediatric,
contraception, infertility, and health disparities related areas. The LRP is an
important component of NIH's efforts to recruit and retain the next generation
of researchers by providing the means for developing a research career
unfettered by the burden of student loan debt. Note that an NIH grant is not
required for eligibility and concurrent career award and LRP applications are
encouraged. The periods of career award and LRP award may overlap providing the
LRP recipient with the required commitment of time and effort, as LRP awardees
must commit at least 50% of their time (at least 20 hours per week based on a
40 hour week) for two years to the research. For further information, please
see: http://www.lrp.nih.gov/.